In the wake of the thalidomide case the US Food and Drug Administration (FDA) excluded women who could become pregnant from Phase I and early Phase II trials to eliminate the risk of harm to foetuses.
Early phase research was focused on as there is insufficient safety data at this stage but the fear of harming an unborn child spilt over into Phase III and created a depression in the number of women in clinical trials.
This created various problems that interested parties have spent the past 30 years attempting to address but Pornima Sood, director of the Women's Heart Health Initiative of Abbott Vascular, believes “industry has been lagging behind”.
Sood believes the industry must work to improve study design, recruitment and enrolment to ensure that gender proportions in clinical trials are representative of the disease’s profile in the general population.
Without these improvements Sood fears ineffective or harmful treatment regimes will reach the market and there is evidence that the knowledge gap has already been detrimental to women.
In her presentation Noel Bairey Merz, director, women’s heat center at Cedars-Sinai, said that since 1984 the mortality rate for cardiovascular disease (CVD) has been higher in women than men.
Merz and others have investigated the problem, looking at how the efficacy of treatments differs in men and women, and believes this, coupled to the efforts by regulators, academics and industry, has helped decrease female CVD mortality rate in recent years.
However, all the speakers acknowledged the need for further work. Sood and Ameeta Parekh, director of for R&D at the FDA’s Office of Women’s Health (OWH), both agreed one aspect of this must be the standardisation of clinical trial data to improve mining and analysis.
Parekh explained that the FDA has a wealth of data but it needs standardising to be useful. Currently gender is denoted in numerous different formats, such as male or M, but the FDA has launched a standardisation programme that will result in clean, usable data.
By continuing efforts to improve the understanding of gender differences Parekh hopes that “one day the knowledge gap will be closed”.